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4. Bulk Production and Distribution:
Unlike traditional pharmacies, which only compound drugs based on individual prescriptions, 503B facilities may produce
large batches of compounded medications in advance. These medications are distributed in bulk to healthcare providers
for use in multiple patients.
The facility must meet all requirements for large-scale production, including detailed labeling, lot tracking, and
documentation for each batch.
5. Quality Assurance and Safety:
503B facilities are subject to FDA inspections and must comply with rigorous quality assurance protocols to ensure that
the compounded medications are safe, effective, and meet regulatory standards.
These facilities must perform routine stability and potency testing, maintain proper documentation of the compounding
process, and provide patients with products that are free from contaminants or errors.
6. Traceability and Recall Procedures:
Outsourcing facilities must have robust systems in place for tracing medications to ensure that they can quickly identify
and recall products if there are safety concerns or if a product is found to be defective.
This is a critical feature to safeguard patient health, especially since 503B facilities supply large quantities of compounded
drugs to healthcare systems.
Key Differences Between 503A and 503B Pharmacies
Focus on compounding medications
for individual patients based on
prescriptions. They are subject to state
pharmacy laws and are not required to
follow CGMPs.
503A PHARMACIES
Can produce medications in bulk for
office use and are subject to FDA
oversight and CGMPs. They are
permitted to distribute compounded
medications to healthcare providers
without individual patient prescriptions.
503B PHARMACIES